PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM

Glucose Oxidase, Glucose

MEDISENSE, INC.

The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Precision Link Blood Glucose Data Management System.

Pre-market Notification Details

Device IDK952279
510k NumberK952279
Device Name:PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM
ClassificationGlucose Oxidase, Glucose
Applicant MEDISENSE, INC. 266 SECOND AVE. Waltham,  MA  02154
ContactMichael Halpin
CorrespondentMichael Halpin
MEDISENSE, INC. 266 SECOND AVE. Waltham,  MA  02154
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-11
Decision Date1995-06-14

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